NCT00081276

3-AP and Cisplatin in Treating Patients With Recurrent or Persistent Platinum-Resistant Ovarian Epithelial or Primary Peritoneal Cancer

A Phase II Evaluation Of Triapine (NCI-Supplied Agent: NSC #663249, IND #68338) In Combination With Cisplatin (Commercially Available: NSC # 119875) In The Treatment Of Recurrent Or Persistent Platinum-Resistant Ovarian Or Primary Peritoneal Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Drugs used in chemotherapy, such as 3-AP and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. This phase II trial is studying how well giving 3-AP together with cisplatin works in treating patients with recurrent or persistent platinum-resistant ovarian epithelial cancer or primary peritoneal cancer

Detailed description

PRIMARY OBJECTIVES: I. Determine the antitumor activity of 3-AP and cisplatin in patients with recurrent or persistent platinum-resistant ovarian epithelial or primary peritoneal cancer. II. Determine the toxicity of this regimen in these patients. SECONDARY OBJECTIVES: I. Determine the duration of progression-free survival and overall survival in patients treated with this regimen. II. Determine the effects of prognostic variables, including initial performance status, age, and mucinous (or clear cell) histology, in these patients. OUTLINE: This is a non-randomized study. Patients receive 3-AP IV over 2 hours on days 1-4 and cisplatin IV over 1 hour on days 2 and 3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed for 5 years. PROJECTED ACCRUAL: A total of 23-48 patients will be accrued for this study within 13 months.

Conditions

• Primary Peritoneal Cavity Cancer
• Recurrent Ovarian Epithelial Cancer
• Stage III Ovarian Epithelial Cancer
• Stage IV Ovarian Epithelial Cancer

Interventions

Type	Name	Description
DRUG	triapine	Given IV
DRUG	cisplatin	Given IV
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2005-07-01
• Primary completion: 2007-01-01
• First posted: 2004-04-08
• Last updated: 2013-01-24

Locations

1 site across 1 country: United States